Effect of Aromatherapy and Music Therapy on Physiological Response and Pain During Mandibular Third Molar Extraction (AROMUSIC-M3)
The goal of this clinical trial is to compare the effects of aromatherapy and music therapy on physiological responses and intraoperative pain in patients with moderate to severe dental anxiety undergoing mandibular third molar extraction. The main questions it aims to answer are:
- Do aromatherapy and music therapy improve physiological responses during mandibular third molar extraction?
- Are there differences between aromatherapy and music therapy in their effects on physiological parameters and intraoperative pain during mandibular third molar extraction? Researchers will compare an aromatherapy group and a music therapy group with a control group to determine whether these interventions improve physiological responses and reduce intraoperative pain.
Participants will:
- Complete the Modified Dental Anxiety Scale (MDAS) before surgery to determine eligibility.
- Receive aromatherapy, music therapy, or standard care for five minutes before the surgical procedure.
- Undergo measurement of blood pressure, heart rate, and oxygen saturation before and after surgery.
- Report intraoperative pain using a visual analog scale (VAS).
研究概览
详细说明
Dental anxiety is common among patients undergoing oral surgical procedures and may be associated with physiological responses that can negatively affect the patient's treatment experience. Mandibular third molar extraction is one of the most frequently performed oral surgical procedures and is often associated with moderate to severe levels of dental anxiety.
Aromatherapy and music therapy have been proposed as non-pharmacological interventions that may improve physiological responses and reduce pain during dental procedures because of their low cost, ease of implementation, and minimal risk. However, evidence comparing the effectiveness of these interventions during mandibular third molar extraction remains limited.
This clinical trial was conducted in a public hospital and included adult patients with moderate to severe dental anxiety who underwent mandibular third molar extraction. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Participants were allocated to an aromatherapy group, a music therapy group, or a control group using a non-randomized allocation method. Group distribution was balanced according to sex. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were recorded before and after surgery. Intraoperative pain was also evaluated using a Visual Analog Scale (VAS).
Clinical characteristics considered in the study included age, sex, abdominal obesity, surgical duration, and mandibular third molar position according to Winter's classification (vertical, mesioangular, and horizontal).
The objective of this study was to compare the effects of aromatherapy and music therapy on physiological responses and intraoperative pain during mandibular third molar extraction and to provide evidence regarding the usefulness of these non-pharmacological interventions in clinical practice.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Lima Province
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Lima、Lima Province、秘鲁、Lima 15082
- Hospital Nacional Arzobispo Loayza - HNAL
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Adults aged 18-38 years.
- Scheduled for mandibular third molar extraction.
- ASA I or ASA II patients.
- Moderate to severe dental anxiety according to MDAS.
Exclusion Criteria:
- Diagnosis of anxiety, depression, or psychiatric disorders.
- Use of antidepressants, antipsychotics, anticonvulsants, beta-blockers, sedatives, or anxiolytics.
- Pregnancy.
- Cognitive, visual, hearing, or language impairment interfering with questionnaire completion.
- Use of sedatives or anxiolytics within 12 hours before surgery.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Aromatherapy
Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction inhaled 1 mL of lavender essential oil through a gauze pad placed approximately 2 cm from the nose, avoiding direct contact, for 5 minutes before surgery.
Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery.
Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery.
Intraoperative pain was assessed using a Visual Analog Scale (VAS).
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Participants inhaled 1 mL of lavender essential oil through a gauze pad positioned approximately 2 cm from the nose, avoiding direct contact, for 5 minutes before mandibular third molar extraction.
其他名称：
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实验性的：Music Therapy
Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction listened to Rachmaninoff's Symphony No. 2, Op. 27, III.
Adagio through wireless headphones for 5 minutes before surgery.
The listening volume was selected by each participant according to personal preference.
Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery.
Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery.
Intraoperative pain was assessed using a Visual Analog Scale (VAS).
|
Participants listened to Rachmaninoff - Symphony No. 2, Op. 27, III.
Adagio through wireless headphones for 5 minutes before mandibular third molar extraction.
The listening volume was selected by the participant.
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无干预：Control
Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction received standard preoperative care without aromatherapy or music therapy.
Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery.
Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery.
Intraoperative pain was assessed using a Visual Analog Scale (VAS).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Heart Rate
大体时间：Before intervention and immediately after surgery
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Heart rate measured in beats per minute (bpm).
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Before intervention and immediately after surgery
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Systolic Blood Pressure
大体时间：Before intervention and immediately after surgery
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Systolic blood pressure measured in mmHg.
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Before intervention and immediately after surgery
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Diastolic Blood Pressure
大体时间：Before intervention and immediately after surgery
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Diastolic blood pressure measured in mmHg.
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Before intervention and immediately after surgery
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Oxygen Saturation
大体时间：Before intervention and immediately after surgery
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Peripheral oxygen saturation measured by pulse oximetry.
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Before intervention and immediately after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intraoperative Pain (VAS)
大体时间：Immediately after surgery
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Pain experienced during mandibular third molar extraction, assessed immediately after surgery using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity (worse outcome).
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Immediately after surgery
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1240-CIEI-CIENTÍFICA-2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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